US6635065B2 - Doppler directed suture ligation device and method - Google Patents

Abstract

Exemplary embodiments are directed to providing a method of preparing an anatomical vessel contained within a tissue bundle for ligation, including positioning a cannula adjacent to the tissue bundle, wherein the positioning is non-penetrating, the cannula including a first extendable member, a second extendable member, a Doppler wand, and a distal end, transmitting ultrasound signals toward the vessel through the tissue bundle with the Doppler wand, receiving ultrasound signals reflected by the vessel through the tissue bundle with the Doppler wand, invaginating the tissue bundle with the first extendable member on a first side of the tissue bundle, invaginating the tissue bundle with the second extendable member on a second side of the bundle opposite the first side, and interpenetrating a length of ligation material between the first and second extendable members on a side of the vessel opposite the cannula distal end.

Description

This is a Continuation-in-Part application of the Original application U.S. patent Ser. No. 09/713,020, filed on Nov. 16, 2000, entitled Doppler Directed Suture Ligation Device and Method by Fred Burbank, Michael L. Jones, Jill Uyeno, Greig E. Altieri, and R. J. Serra.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to ligation devices and methods, and more particularly to devices and methods for accurately locating and ligating an anatomical vessel.

2. Brief Description of the Related Art

The Doppler effect is currently utilized in many fields. For example, Doppler stethoscopes and Doppler wands are currently utilized to listen to the blood flow within the anatomical structures in patients, especially in mammalian patients. Continuous wave Doppler sound signals are used to identify blood vessels, but do not provide feedback as to the distance of the vessel from the Doppler probe used. Pulsed wave Doppler has been used to identify blood vessels and, in conjunction with two dimensional (2D) imaging systems, identify the distance to a blood vessel and blood flow characteristics. Ultrasound systems with Doppler imaging are also currently used in medical fields, and typically produce gray-scale two-dimensional images. The addition of Doppler processing allows for the evaluation of fluid flow velocities through fluid conduits within the patient, and the relative position of these vessels to other anatomical structures.

Ligation devices have previously been proposed. These prior ligation devices have typically been used in laparascopic procedures, and have typically required that the anatomical feature of interest be dissected or visualized prior to ligation of that feature. Other ligation devices require the penetration of a tissue bundle encapsulating the anatomical vessel in order to perform location and ligation of the vessel.

The tissue of the vaginal wall is very elastic, pliable, and flexible. The vaginal wall can made to assume different shapes without tearing and without significant patient discomfort or pain. Heretofore, this inherent characteristic of these tissues has not been utilized in the area of tissue ligation.

SUMMARY OF THE INVENTION

According to a first exemplary embodiment, a method of preparing an anatomical vessel contained within a tissue bundle for ligation, comprises the steps of positioning a cannula adjacent to the tissue bundle, wherein the positioning is non-penetrating, the cannula including a first extendable member, a second extendable member, a Doppler wand, and a distal end, transmitting ultrasound signals toward the vessel through the tissue bundle with the Doppler wand, receiving ultrasound signals reflected by the vessel through the tissue bundle with the Doppler wand, invaginating the tissue bundle with the first extendable member on a first side of the tissue bundle, invaginating the tissue bundle with the second extendable member on a second side of the bundle opposite the first side, and interpenetrating a length of ligation material between the first and second extendable members on a side of the vessel opposite the cannula distal end.

According to a second exemplary embodiment, a ligation device for invaginating a vessel contained within a tissue bundle comprises a means for noninvasively positioning a cannula about the tissue bundle, the cannula including a Doppler wand and a distal end, a means for transmitting ultrasound signals toward the vessel through the tissue bundle with the Doppler wand, a means for receiving ultrasound signals reflected by the vessel through the tissue bundle with the Doppler wand, a first means for invaginating the tissue bundle on a first side of the tissue bundle, a second means for invaginating the tissue bundle on a second side of the bundle opposite the first side, and a means for interpenetrating a length of ligation material between the first and second invaginating means on a side of the vessel opposite the cannula distal end.

Still other objects, features, and attendant advantages of the present invention will become apparent to those skilled in the art from a reading of the following detailed description of embodiments constructed in accordance therewith, taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention of the present application will now be described in more detail with reference to preferred embodiments of the apparatus and method, given only by way of example, and with reference to the accompanying drawings, in which:

FIG. 1 illustrates a top, distal, side perspective view of an exemplary embodiment of a Doppler directed ligation device in accordance with the present invention;

FIG. 2 illustrates the ligation device of FIG. 1, with portions removed;

FIG. 3 illustrates a cross sectional view taken alongline3—3 in FIG. 1;

FIGS. 4-6 illustrate a snare in accordance with the present invention;

FIG. 7 illustrates an enlarged perspective view of the distal end of the embodiment illustrated in FIG. 1;

FIGS. 8-10 illustrate a loop in accordance with the present invention;

FIGS. 11-13 illustrate portions of the device illustrated in FIG. 1;

FIG. 14 illustrates a portion of the device illustrated in FIG. 1;

FIG. 15 illustrates an enlarged view of the portions illustrated in FIG. 14;

FIG. 16 illustrates a cross sectional view taken alongline16—16 in FIG. 1;

FIGS. 17-19 illustrate enlarged plan views of further embodiments in accordance with the present invention;

FIGS. 20-24 illustrate the device of FIG. 1 used in accordance with an exemplary embodiment of a method of ligating an anatomical feature in a patient;

FIG. 25 illustrates portions of yet another embodiment of the present invention;

FIGS. 26A and 26B illustrate portions of further embodiments of the present invention;

FIGS. 27-30 illustrate several views of yet another embodiment in accordance with the present invention;

FIG. 31 illustrates the device of FIG. 1 used in accordance with an exemplary embodiment of a method of ligating a uterine artery in accordance with the present invention;

FIG. 32 illustrates the device of FIG. 1 used in accordance with an exemplary embodiment of a method of ligating an anatomical feature in a patient by invagination;

FIG. 33 illustrates the device of FIG. 1 used in accordance with an exemplary embodiment of a method of ligating an anatomical feature in a patient by penetration; and

FIG. 34 illustrates the device of FIG. 27 used in accordance with an exemplary embodiment of a method of ligating an anatomical feature in a patient by invagination.

DESCRIPTION OF PREFERRED EMBODIMENTS

Referring to the drawing figures, like reference numerals designate identical or corresponding elements throughout the several figures.

FIG. 1 illustrates a top, distal end, side perspective view of an exemplary embodiment of a Doppler directedligation device100 in accordance with the present invention. FIG. 1 illustratesdevice100 deployed to enable a practitioner to ligate afluid vessel10. Whilevessel10 is preferably a uterine artery, other vessels, such as other arteries, veins, fallopian tubes, urinary ducts such as the ureter, and other fluid vessels can be ligated withdevice100 within the spirit and scope of the present invention, as will be readily appreciated by one of ordinary skill in the art. Different from ligation devices which have previously been proposed, as well as their uses, ligation devices and methods in accordance with the present invention do not require dissection of thevessel10, and does not require actual visualization of the vessel, prior to ligation. The capability enabled by the present invention of invaginally advancing a ligation device either through or around tissue beds and/or tissue planes without the need for dissection or tissue penetration in order to locatevessel10 can provide benefits as described elsewhere herein and as will be readily appreciated by one of ordinary skill in the art.

Ligation device100 includes aproximal handle102 and acannula104 extending distally from the handle. Handle102 includes ahollow housing103 sized and shaped to fit comfortably in the hand of a practitioner. Aproximal thumb ring106 is fixed to thehousing103opposite cannula104. A pair oftop slots108,110 are formed in thetop surface107 of thehousing103, and a pair ofside slots109,111, are formed in thesidewalls113,115. Afirst actuation ring112 and asecond actuation ring114 are slidably mounted inhousing103, through theopposite side slots109,111 (see also FIG. 2) of the housing.Upstanding tabs116,118, extend from the interior ofhousing103, throughslots108,110, respectively, to outside the housing. Theslots109,111 limit the range of motion of therings112,114, and theslots108,110 function to limit the range of motion of thetabs116,118 along longitudinal direction X.

Cannula104 is fixedly mounted to the distal end ofhandle102. Cannula104 includes a plurality of lumenae extending longitudinally through the cannula, which are best illustrated in FIG.3.Ligation device100 includes a firstextendable element120 which is longitudinally slidable throughcannula104 between a retracted position (see, e.g., FIG. 20) in which the first extendable element is housed entirely inside the cannula, and an extended position (see, e.g., FIG. 21) in which the first extendable element extends distally beyond thedistal end150 of the cannula. Ligation device also includes a secondextendable element122 which, similar to firstextendable element120, is longitudinally slidable throughcannula104 between retracted and extended positions. First and secondextendable elements120,122 are connected to first and second actuation rings112,114, respectively, at the proximal ends of the extendable elements, so that the rings can be used to longitudinally advance and retract the extendable elements incannula104.

The first and secondextendable elements120,122 are positioned laterally opposite each other incannula104, as best illustrated in FIG. 3, so that when they are in their extended positions they can be positioned on opposite sides of an anatomical vessel, such asvessel10. Furthermore, first and secondextendable elements120,122 are sized so that they both are extendable farther than a distance X_reffrom thedistal end150, described in greater detail below, so that avessel10 can be bracketed by the extendable elements when the vessel is within X_reffrom the distal end ofcannula104.

Firstextendable element120 carries a detachable element at its distal end. In the embodiment illustrated in FIG. 1, the detachable element is aloop124.Loop124 is attached, either directly or indirectly as will be described in greater detail below, to a length of threadlike material, such as suture material, which may optionally further include a leader, which extends proximally throughcannula104. Secondextendable element122 carries a snare element which is sized and configured to grab, ensnare, or otherwise become secured with the detachable element of the firstextendable element120 when the first and second extendable elements are in their extended positions (see FIGS.1 and23). In the embodiment illustrated in FIG. 3, the snare element is ahook126.Loop124 and snare126 will be described in greater detail below with reference to FIGS. 4-13.

Ligation device100 further includes a Doppler ultrasound device orwand140 mounted in the ligation device. In accordance with the present invention, the Doppler ultrasound device can be removably mounted in the ligation device, or the components of a Doppler ultrasound device can be integrated into the ligation device, e.g. intocannula104, so as not to be removable. Thus, when the Doppler ultrasound device is removably mounted inligation device100, the Doppler ultrasound device can be removed at the termination of a use, removed from the remainder of the ligation device, and the Doppler ultrasound device sterilized and reused. Alternatively, when the Doppler ultrasound device's components are integrated into theligation device100, the entire ligation device can be disposed of at the conclusion of a use.

Cannula104 includes a third center lumen138 (see FIGS. 3 and 7) into which aremovable Doppler wand140 is removably inserted. According to certain embodiments of the present invention, adistal end152 of the Doppler wand is proximal of thedistal end150 of the cannula. According to other embodiments of the present invention, thedistal end152 of theDoppler wand140 is positioned at thedistal end150 of the cannula. According to other embodiments of the present invention, thedistal end152 of theDoppler wand140 is positioned distal of thedistal end150 of the cannula. Preferably,housing103 includes portions which receive the proximal portions ofDoppler wand140, so that the Doppler wand can be removed and reused afterligation device100 has been used. For example and not by way of limitation,housing103 can include portions which are hinged together and secured with a snap, lock, or the like, so that the housing can be opened up, aDoppler wand140 inserted intoligation device100, and the housing portions closed and locked to secure the Doppler wand in the ligation device.

Doppler ultrasound wands suitable for use in the present invention are presently commercially available. For example, Koven model ES 100X MiniDop VRP-8 probe (St. Louis, Mo.) is a Doppler wand suitable for use asDoppler wand140, and DWL/Neuro Scan Medical Systems' Multi-Dop B+ system with their 8 MHz handheld probe (Sterling, Va.) is a continuous and pulsed wave Doppler wand suitable for use aswand140. Commercially available Doppler stethoscopes or wands have an ultrasound dispersion pattern which is generally conical, i.e., the wand “looks” out along a cone-shaped portion of a plane originating at the end of the wand. Thus, vessels with fluid flow in them, such as a blood vessel, which lie anywhere in this conical plane and within the effective range of the wand would be picked up by the wand. Doppler wands presently available are attached to a signal processing anddisplay unit156, which processes the electrical signals generated bywand140 to generate displays and/or other data derived from the electrical signals for additional uses. Alternatively, the Doppler system can be gated to identify blood vessels within a predetermined distance range, e.g. from between 0 to 5 cm, more preferably between 0.5 and 3 cm.

Unit156 includes adisplay158 which indicates the distance from thedistal tip152 the source of reflected ultrasound waves is located, e.g.,vessel10. This information is typically calculated utilizing a predetermined function, because the distance is a function of the time it takes for the ultrasound waves to travel to and from the wand.Unit156 preferably also includes a display ormeter160 of the magnitude of the reflected ultrasound waves's Doppler shift, which is the indication of the velocity of the fluid flowing throughvessel10.Unit156 also preferably includes asound source162 which gives an audible indication of the Doppler shift, which can be louder when the Doppler shift is greater or the vessel is optimally positioned.

In the ligation device of the present invention, however, such a wide conical “field of view” typically returned by many commercially available Doppler wands is not preferable, because the practitioner is concerned with locating the vessel between the extendable elements in order to ligate the vessel. Were the present invention to utilize such “wide-view” Doppler wands without narrowing or otherwise affecting their field of view, vessels which are not directly distal ofligation device100 would be picked up by the device, and would return Doppler shift data for vessels not of interest in the use of the ligation device.Ligation device100, and specifically cannula104, is therefore sized so that thedistalmost end152 ofDoppler wand140 is spaced proximally from thedistal end150 of the cannula, for use with “wide-view” wands to collimate the signal. Some commercially available Doppler wands, such as the aforementioned DWL probe, however, produce a sufficiently collimated signal so that further collimation is not necessary.

When utilizing a Doppler probe which does not produce a sufficiently collimated signal,lumen138 is preferably coated, formed of a material, or is otherwise provided with a sleeve of a material on the interior surface of which collimates the sound waves emanating fromDoppler wand140. By way of example and not of limitation,lumen138 can be coated or formed of polycarbonate, although other materials are also usable within the spirit and scope of the present invention.

The result of spacingdistal end152 proximally ofdistal end150, and optionally further providing a material and/or sleeve which acoustically collimates the ultrasound waves fromwand140, is thatligation device100 is substantially unidirectional in its Doppler field of view in a direction parallel with, and preferably between, first and secondextendable elements120,122, and longitudinally distal ofdistal end150. Stated differently,ligation device100 is capable of receiving reflected ultrasound waves, originating fromDoppler wand140, reflected back from anatomical features directly distal ofdistal end150. Thus, becausedistal end152 is a fixed and known distance fromdistal end150, and X_refis known, a maximum distance X_maxis predetermined by the structures ofligation device100 within which avessel10 must be in order for the ligation device to be capable of ligating it. Stated somewhat differently, once it is determined that a vessel is within a predetermined distance ofdistal end152, which is indicated by the time lag of the reflected ultrasound waves,ligation device100 can be used to ligate that vessel.

According to another embodiment in accordance with the present invention, a Doppler wand can be chosen which has a “field of view” which is narrow enough that, when used in the combination of theligating device100, additional collimation structures are not necessary. For example, selection of a probe is based on its field of view and its operating frequency, and should also be based on the distance between the target artery and the Doppler probe so that the probe's depth of view is larger than this distance yet not so long as to include other blood vessels. By way of example and not of limitation, a Koven Doppler probe as described above can be used aswand140 without requiring either a collimating sleeve and without spacing the distal end proximal ofdistal end150. In general, Doppler wands suitable for use asDoppler wand140 are selected with small enough diameter to be insertable incannula104, preferably operate at a frequency which is sufficiently sensitive to blood flow to monitor uterine artery blood flow, have a relatively narrow field of view and limited depth of view so as not to generate a signal from other blood vessels, and can be based on either pulsed or continuous wave Doppler signals.

FIG. 3 illustrates a cross-section view ofligation device100, as seen alongline3—3 in FIG. 1, and FIG. 7 illustrates an enlarged distal end perspective view ofligation device100.Cannula104 preferably has an oval cross sectional profile, so that the cannula can be relatively compact while still meeting the requirement thatDoppler wand140 be laterally betweenextendable elements120,122. As illustrated in FIG. 3,cannula104 includes afirst lumen130 which longitudinally and slidingly receives firstextendable element120. Preferably,element120 itself includes alumen142 through which a tubular suture andloop advancing element134 is longitudinally slidable.Element120 further optionally is provided with a slot orcutout170 at its distal end in the wall of theelement120 adjacent to or facingelement122, to assist in guiding or positioningloop advancing element134 in a desired direction and to assist in preventing rotation of the loop advancing element relative to theelement120.

Suture advancingelement134 at least in part is formed of a superelastic material, less preferably a shape-memory alloy (SMA) material, also less preferably (surgical) stainless steel. NiTi (nitinol) is preferred, although other superelastic, SMA, and biocompatible materials are within the scope of the present invention. Forming at least portions ofsuture advancing element134 of NiTi allows the suture advancing element to be preformed with a curved distal end, so that the suture advancing element can be easily retracted into firstextendable element120, yet the distal end will accurately positionloop124 to be snared byextendable element122 when the suture advancing element is advanced out of the first extendable element.

Suture/loop advancing element134 preferably is a hollow tube and includes structure at the distal end of the element which holdsloop124, the loop in turn being attached to a length of suture material154 (see also FIG.24). A more detailed description of the structures at the distal ends ofextendable elements120,122 is presented below with reference to FIGS. 4-13.

Cannula104 includes asecond lumen132 in which secondextendable element122 is longitudinally slidably received. Secondextendable element122 preferably includes alumen144 which longitudinally slidably receives an extendible hooking or snaringelement136.Cannula104 also includes athird lumen138 which removably receivesDoppler wand140, so that the Doppler wand can be used with the other structures ofligation device100 and then disassembled, as discussed above. Optionally, theligation device100, including thethird lumen138, can non-removably house the functional components of a Doppler wand, so that the entire ligation device can be conveniently disposed of.

As illustrated in FIG. 7, the first and secondextendable elements120,122 can optionally further be provided with closed, preferably conically or frustoconically shapedtips121,123, respectively. Theclosed tips121,123 permit theextendable elements120,122 to be more easily advanced through tissue beds and planes. As described herein concerning another embodiment of the present invention, theextendable elements120,122 may also invaginate the tissue beds and planes without penetration of the tissue, because of the inherent flexibility or pliability of the vaginal wall tissue. When provided with theclosed tips121,123, theextendable elements120,122 further include laterally inwardly facingopenings125,127 so that theelements134,136 can pass out of theelements120,122, as described elsewhere herein. Further optionally, the distal interiors of one or both of the closed tips can be provided with cam surfaces (not illustrated) to assist in guiding the detachable elements and/or the snaring elements.

FIGS. 4-6 illustrate several views of snaringelement136 including hook orsnare126. As detailed in FIG. 5, snare126 includes anenlarged head160 having anangled slot162. Ahook portion164 is formed distally ofslot162.Slot162 has a width W₁and extends intohead160 at an angle α. Ashank166 is attached at the proximal end ofhead160, and is preferably formed integrally therewith from a single piece of material. Alternatively,shank166 andhead160 can be press-fit, welded, adhesively bonded, or otherwise formed separately and thereafter joined together as will be readily apparent to one of ordinary skill in the art. Width W₁is selected to be greater than the width W₂of loop124 (see FIG.9), so that the loop can be deflected intoslot162 byhook portion164 and slide into the slot and be grabbed bysnare126. Optionally, the proximal portions ofhead160 adjacent to the opening to slot162 can be widened, as indicated in phantom lines in FIG. 5, which can facilitateloop124 being deflected byhook portion164 intoslot162.

FIGS. 8-13 illustrate distal end portions of suture/loop advancing element134. As illustrated in FIGS. 8-10,loop124 is preferably roughly oval in shape, and is temporarily mounted to the distal end of a tubular curved element172 (see also FIG.13). A length ofsuture material154 or the like is tied, glued, crimped, or otherwise secured toloop124, and extends proximally throughtube172. As illustrated in FIGS. 11-13, suture/loop advancing element134 includes astraight portion174 and acurved portion172, both of which are hollow tubes.Straight portion174 andcurved portion172 are joined together at a joint180. Optionally,element134 can be a monolithic element without such a joint180, and astraight portion174 and acurved portion172 can be formed therein, as will be readily appreciated by one of ordinary skill in the art.

At leastcurved portion172 ofelement134 is preferably formed of a superelastic material. Alternatively,portion172 can be formed of a SMA material. While the characteristics and use of superelastic materials are readily appreciated by one of ordinary skill in the art, a brief description as applied tocurved portion172 will aid in an understanding of the present invention.Portion172 is preferably formed of a superelastic material, e.g., NiTi (nitinol).Portion172 is given a curvature or bent configuration which, upon heating of the curved portion above a certain temperature for the superelastic material, is ‘remembered’ by the curved portion. In the embodiment illustrated in FIGS. 11-13curved portion172 is formed into an arc having a radius R and thedistal end176 being at an angle β from a line perpendicular tostraight portion174.Distal end176, whencurved portion172 is in its curved configuration, is a lateral distance Y from thestraight portion174.

The length ofcurved portion172 and the shape, as well as the distance Y, are selected so that whencurved portion172 is in its curved configuration,loop124 is positioned directed distally of secondextendable element122. In this location, snare126 can be extended and can hookloop124, to be pulled from suture/loop advancing element134. The angular orientation of the lateral direction in which curvedportion172 extends when in its curved configuration can be preset so thatloop124 registers or lines up withsnare126, and slot170 assists in maintaining this orientation. This present angular orientation can be determined, by way of example and not of limitation, by heatingcurved portion172 above its transition temperature androtating element134 untilloop124 is directly distal ofsnare126, prior to usingdevice100.

Curved portion172 andstraight portion174 can both be formed of the same (superelastic) material. Alternatively,only portion172 is formed of an superelastic material, andstraight portion174 can be formed of another material, e.g., stainless steel, and the twoportions172,174 can be joined together at joint180, as by welding, crimping, swaging, adhesive bonding, or the like. The distalmost end ofportion172 includes aslot178 in whichloop124 is temporarily held.Slot178 has a width W₃and a depth D selected so thatloop124 can be received therein by a press fit, or loosely received and crimped therein.Loop124 is not permanently held inslot178, however, and is mounted in the slot so that the loop can be pulled out of the slot by a preselected force transmitted bysnare126 after the loop has been hooked by the snare (see, e.g., FIG.3).

FIG. 14 illustrates internal portions ofligation device100. First and secondextendable elements120,122 are mounted in ablock190 to which rings112,114 are also fixedly secured. Thus, as described above, proximal and distal longitudinal movement ofrings112,114 moves first and secondextendable elements120,122.Block190 includes a pair ofslots192,194 formed in a top surface thereof in which tabs or pins116,118 are slidably received, respectively. Thus, theslots192,194 constrain thetabs116,118 laterally, while permitting them to move longitudinally over a range limited by the length of the slots.

FIG. 15 illustrates a top plan view of distal portions of the view illustrated in FIG.14. As can be seen in FIG. 15, theblock190 includesslots192,194, described above. According to one embodiment of the present invention, block190 includes first and secondlateral portions196,198, which are cylindrical in shape, in which the first and secondextendable elements120,122 are mounted, respectively. According to one embodiment of the present invention,lateral portions196,198 can be fixedly joined together as a with aweb200, so that movement of one of therings112,114 moves both lateral portions. According to yet another embodiment of the present invention,lateral portions196 and198 are not joined together, and are therefore separately and individually longitudinally moveable inhousing103.

Also visible in FIG. 15 are mountingblocks202 and204 positioned inblock190. Mountingblock202 fixedly receives the proximal portion ofextendable element134 and lower portions oftab116, and mountingblock204 fixedly receives the proximal portion ofextendable element136 andtab118.Block202 thus joins togetherextendable element134 withtab116, and block204 thus joins togetherextendable element136 withtab118. Additionally, blocks202 and204 constraintabs116 and118 from being pulled up and out fromblock190, as their lateral extents are larger thanslots192,194, respectively.

FIG. 16 illustrates a cross-sectional view of proximal portions ofligation device100. As can be seen in FIG. 16, thehousing103 includes an interior chamber orcavity210 which slidingly receives block190 and its components.Block190 includes an interior chamber orcavity208 which slidingly receivesblocks202 and204 (block204 is not visible in the view of FIG.16), and aproximal opening206 which communicatesinterior chamber208 withinterior chamber210.Proximal opening206 also permitsblocks202,204 to extend intointerior chamber210. FIG. 16 also illustratessuture154 extending throughloop advancing element134, block202,interior chamber208,interior chamber210, and exitinghousing103 through one of slots108-111.

FIGS. 17-19 illustrate further embodiments in accordance with the present invention. In the embodiment illustrated in FIG. 17, both aloop advancing element220 and asnare advancing element222 are formed of a superelastic, SMA, or stainless steel material, and curve to meet each other. In the embodiment illustrated in FIG. 18,snare advancing element136 is formed of a superelastic, SMA, or stainless steel material, andloop advancing element134 is advanced directly longitudinally distally to be snared by thesnare126. In the embodiment illustrated in FIG. 19, a firstcurved tube230 of a superelastic, SMA, or stainless steel material, and a secondcurved tube232 of a superelastic, SMA, or stainless steel material, meet in a manner similar to the embodiment illustrated in FIG.17. The distal ends oftubes230,232 mate in a somewhat different fashion, one of thetubes230,232 bearing a snare which is areceptacle234 having abore238 having an internal diameter larger than the external diameter of the other oftubes230,232. Thus, when thetubes230,232 meet, the distal ends engage. A pushrod orwire236, to whichsuture154 is attached, is positioned in one of the lumens oftubes230,232, and is pushed distally down that tube, throughreceptacle234, and proximally up the other oftubes230,232. Thus, a suture can be advanced around a blood vessel of interest in a manner similar to the embodiments described above.

FIGS. 20-24 illustrate several steps of an exemplary method in accordance with the present invention. While FIGS. 20-24 illustrate, and the following description makes reference to,ligation device100, methods in accordance with the present invention are not limited to use ofligation device100, and other apparatus can be utilized in practicing the present methods without departing from the spirit and scope of the present invention.

FIG. 20 illustrates the distal end ofligation device100 after having been positioned proximate a vessel of interest in a patient, e.g., auterine artery10.Distal end150 ofcannula104 is initially positioned away fromvessel10.Distal end150 is accurately positioned within X_maxof the vessel by pointingcannula104 in several directions around where the practitioner believes the vessel is located, monitoring the output ofunit156 for distance and velocity data to determine the relative location of the vessel relative todistal end150, and repositioning the distal end until the distal end is a distance X fromvessel10 less than X_max. As described above, reflected ultrasound waves182, which are preferably collimated, are received by Doppler wand140 (or the functional components thereof, integrated into ligation device100) and are processed byunit156 to indicate the relative location ofvessel10. For example, Doppler sound is utilized to find the vessel location, and thereafter pulsed wave Doppler is utilized to identify a more precise location and the distance to theartery10.

Once the practitioner has established thatvessel10 is directly distal of thedistal end150 ofcannula104, first and second actuation rings112,114 are moved distally to move first and secondextendable members120,122 distally, as illustrated in FIG.21. In yet another embodiment of the present invention, the first and secondextendable members120,122 invaginate the tissue of the vaginal wall, and the underlying tissue beds, adjacent tovessel10 by non-penetration such that the vessel is bracketed on two sides by invaginated tissue andmembers120,122. Then, as illustrated in FIGS. 22 and 23, suture/loop advancing element134 and snaringelement136 are both distally advanced by pushingtabs116,118 distally; the advancement ofelements134 and136 can be serial, simultaneous, or combinations thereof. Because suture/loop advancing element134 is inside a (preferably mammalian) patient while it is advanced, the suture/loop advancing element is heated up in situ above its SMA transition temperature, and transforms from its straight configuration to its ‘remembered’ or curved configuration. Thus, advancement of advancingelement134 out ofmember120 is accompanied byelement134 assuming, or having already assumed, its curved configuration.Element134 andloop124 are therefore advanced in a lateral direction and towardelement136 andsnare126.

While theloop124 is positioned directly distal ofsnare126, snaringelement136 is moved distally to advancesnare126 distally. Snare126, and more particularlyhead160, entersloop124, and is pushed through the loop. Snare126 is then retracted proximally so thathook portion164 deflectsloop124 intoslot162, thus causing the loop to be grabbed by the snare. In this respect, a widened mouth to slot162, as suggested byphantom line168, can facilitate capture ofloop124.

Withloop124 ensnared bysnare126, snaringelement136 is retracted proximally, which pulls on the loop in a proximal direction. As the materials out of whichportions172,174 are formed are relatively rigid (superelastic, SMA, and stainless steel being preferable), the force applied by snaringelement136 toloop124 will cause the joint betweenloop124 and slot178 to break or otherwise release the loop fromelement134. As will be readily appreciated by one of ordinary skill in the art, the joint betweenloop124 andslot178 is designed as a breakaway element, with the minimum force needed to break the joint selected so that the loop will not prematurely break free ofcurved portion172, yet not so high that a practitioner will not readily be able to generate the required force by pulling proximally ontab118. Onceloop124 has been broken free ofslot178, snaringelement136 and secondextendable element122 are further pulled proximally so that the loop is pulled intocannula104. As described above,suture material154 extends throughcurved portion172 and is secured toloop124, and is therefore pulled along with the loop.

Thus,suture material154 is advanced distallypast vessel10 by distal extension of firstextendable element120 and suture/loop advancing element134, is advanced laterally behind the vessel bycurved portion172 having assumed its curved superelastic configuration, and is advanced proximally by proximal retraction ofloop124 after having been grabbed bysnare126. Alternatively, thesuture material154 is advanced distallypast vessel10 by non-penetrating, distal invagination of tissue by the firstextendable element120, and suture/loop advancing element134 is advanced to penetrate laterally behind the vessel bycurved portion172 having assumed its curved superelastic configuration, and is thereafter advanced proximally by proximal retraction ofloop124 after having been grabbed bysnare126. With the loop of suture material passing aroundvessel10,ligation device100 can be pulled proximally, leaving the loop of suture material aroundvessel10, as illustrated in FIG.24. At this point, the practitioner can make whatever form of ligation she chooses, as the loop of suture material has been accurately passed around thevessel10 of interest.

FIG. 25 illustrates yet another embodiment in accordance with the present invention. The embodiment illustrated in FIG. 25 is similar to that illustrated in FIG. 3, but differs in the cross-sectional profile of thedevice250. Instead of the oval cross-sectional profile illustrated in FIG. 3,device250 includes thecoplanar lumenae130,132,138 defined in three adjacent and joinedtubes252,254,256.

FIGS. 26A and 26B illustrate alternative embodiments useful for passing and ensnaring suture material, such assuture material154, asdevices260,280. Thedevice260 includes a detachable arrowhead shapedelement262 at the end of suture/loop advancing element134 to which a length of ligation material is attached as discussed elsewhere herein. A inwardly laterally directedopening264 is formed in the end of snaringelement136. Theopening264 has an inner dimension selected so that thearrowhead element262 will pass into thepassageway264 when properly aligned therewith. Once thearrowhead element262 has passed into theopening264, the snaringelement136 can be retracted in a manner similar to that described above, causing thearrowhead element262 to be caught and ensnared in the interior of the snaring element, and thereafter detached from theelement134. The snaringelement136 can optionally further be provided with a second opening266 (indicated in phantom) opposite thefirst opening264, so that thearrowhead element262 can be passed entirely through the snaring element to be ensnared.

Further optionally, theelement134 can be electrically insulated on its exterior surface proximal of thedetachable arrowhead262, as indicated by dithering268, andelement136 can similarly be electrically insulated on its exterior surface proximal of apreselected point270, as indicated by dithering272. When provided with this electrical insulation, thearrowhead262 and theportion274 of theelement136 distal of thepoint270 can be electrically connected to opposite poles of a bipolar RF electrical energy source (not illustrated) and the arrowhead can be used as an RF cutter to easily push through tissue beds and tissue planes which lie between it and theopening264. For example, proximal portions of theelements134,136 can be electrically connected to an RF energy source to permit thearrowhead262 to act as an RF cutter, as will be readily appreciated by one of ordinary skill in the art.

FIG. 26B illustrates aspects of yet another alternative embodiment in accordance with the present invention,device280.Device280 is similar in some respects todevice260.Device280 includes adetachable ball282 mounted at the distal end ofelement134. Theball282, when advanced intoopening284 or through to opening286, is ensnared by the snaringelement136 in a manner similar to that described elsewhere herein.

FIGS. 27-30 illustrate several views of yet another embodiment in accordance with the present invention. Turning to FIG. 27, anextendible element300 is illustrated with portions removed to aid in a better understanding of the extendible element.Element300 can be used instead of any of the above-described extendible elements, e.g.,elements120,122.

Element300 includes a longitudinally extending cannula ortube302 having ahollow interior303. Astationary guide tube304 is mounted in thecannula302 and has adistal end305 which is positioned proximally of the distal end of thetube302. Theguide tube304 is provided to guide a pushrod or the like carrying a length of suture material (not illustrated) toward the distal end of thetube302. A pair of wire guides306,308 are mounted to the top and bottom of the of theguide tube304 adjacent to its distal end, and extend distally out of thedistal end305 of the guide tube. Theguides306,308 are preferably formed of a flexible material and are flat in cross-section so that when a suture-bearing pushrod or the like is advanced out the distal end of theguide tube304, the pushrod is caused to follow a path between the wire guides306,308.

The distal ends of the wire guides306,308 are positioned in ahollow arm310, and are preferably not secured to the hollow arm. Thearm310 is attached to thecannula302 at apivot326. Thecannula302 includes a window, cutout, orfenestration320 adjacent to thearm310, and is sized and positioned so that thearm310 can rotate between a deployed orientation, illustrated in FIGS. 27 and 28, and a retracted orientation, illustrated in FIG. 29, without hitting or otherwise interfering with the cannula. Thearm310 can have any of a number of cross-sectional configurations, including the somewhat rectilinear shape illustrated in the embodiment of FIGS. 27-30.

Theelement300 also includes two pulling elements with which the orientation of thearm310 can be controlled. In the embodiment illustrated in FIGS. 27-30, the pulling elements include a pair ofupper pullwires312,314, which extend from within proximal portions of thecannula302 to anattachment region350 on thearm310. The pulling elements also include a pair oflower pullwires316,318, which extend from within proximal portions of thecannula302 to anattachment region352 on thearm310. As theattachment regions350,352 are on opposite sides of the arm310 (top, bottom, respectively), pulling on the pullwire pairs will result in moving the arm to either the deployed orientation or the retracted orientation. More specifically, pulling on theupper pullwire pair312,314 causes the arm to rotate clockwise (in the view illustrated in FIG.27), So that the arm extends generally transverse to thecannula302. Conversely, pulling on thelower pullwire pair316,318 causes the arm to rotate counterclockwise (again, in the view illustrated in FIG.27), so that the arm is within the cannula's hollow interior and extends longitudinally.

Theelement300 preferably includes one or more structures which facilitates operation of theupper pullwires312,314. Aport328 is preferably formed through the cannula wall somewhat proximally of thefenestration320, and the upper pullwire pair extends through this upper port. Additionally, a groove ortrough330 is optionally formed in the outer surface of the cannula between theport328 and thefenestration320. Thetrough330 is sized to be deep enough to receive the upper pullwire pair so that when thearm310 is in the retracted orientation, the pullwires are positioned in the trough and do not extend much or at all beyond the outer diameter of the cannula. FIGS. 29 and 30 illustrate thearm310 in the retracted orientation, and theupper pullwires312,314 positioned in thetrough330. Thus, the proximal lip of theport328 acts as a bearing surface for theupper pullwires312,314 as they move longitudinally and thearm310 pivots aboutpivot326.

Theelement300 preferably includes structure which permits the lower pullwires to rotate thearm310. In the embodiment illustrated in FIGS. 27-30, ayolk322 is positioned in thecannula302 with the lower pullwires316,318 extending around the yolk. FIGS. 28 and 30 better illustrate details of theyolk322. Theyolk322 is mounted in thecannula302 distally of thepivot point326 and preferably below the pivot point. As will be readily appreciated from FIGS. 27-30, pulling proximally onpullwires316,318 results in thearm310 rotating down into thecannula302 through thefenestration320, and into the retracted orientation. For ease of positioning theyolk322 into theelement300, thecannula302 may optionally include anopening332 into which the yolk partially extends. Theopening332 can be eliminated.

Also illustrated in FIG. 27 is astationary tube324 which extends along the bottom of thecannula302. Thestationary tube324 is provided so that a practitioner can advance other tools through theelement300 without interfering with the operation of thearm310. By way of example and not of limitation, tools such as an anesthesia needle or the like can be advanced distally through thetube324 from its proximal end (not illustrated) to its distal end336 (see FIG.28). Thearm310 also preferably includes acutout portion340 on the upper surface of the arm (when in the retracted position; on the proximal face when in the deployed orientation) through which the wire guides306,308 extend. Thecutout340 is provided so that a pushrod carrying a suture (not illustrated) can follow a path into thearm310 which is more gently curved than if the cutout is not provided, and therefore the cutout facilitates use of theelement300 to pass a length of suture material around a blood vessel.Fingers354,356 are also optionally provided adjacent to structures in theelement300 on which a suture may snag during deployment, such asattachment portion350 and the proximal end of the wire guides306,308. Thefingers354,356 provide a ramp to deflect the advancing suture away from the structure against which the suture may snag, and therefore facilitate use of theelement300.

Turning now to FIG. 28, theelement300 preferably includes a distalmost taperedtip334 in which thedistal port336 of thetube324 is formed. Thetip334 optionally includes ablind bore338 in its interior which facilitates assembly of the tip to thecannula302. Also illustrated in FIG. 28 is theyolk322 secured to the interior of thecannula302 with thestationary tube324 extending over the yolk and for which the yolk is provided with a unique shape.

FIG. 29 illustrated theelement300 with thearm310 in its retracted orientation resulting from the lower pullwires316,318 having been pulled proximally. As illustrated in FIG. 29, the free distal ends of the wire guides306,308 are, when thearm310 is in the retracted orientation, preferably within the hollow interior of the arm, so that the wire guides do not interfere with the arm passing through thefenestration320 and into the interior of thecannula302.

FIG. 30 illustrates a cross-sectional view of theelement300, taken at line30-30 in FIG.29. Beginning at the top of the figure, theupper pullwires312,314 are illustrated in thetrough330. The exemplary cross-sectional shape of the arm310 (rectilinear) can be seen as well as the generally rectilinear cross-sectional shape of theguide tube304. Theyolk322 includes a pair ofarms342,344, which are secured to the interior of thecannula302. A U-shaped curvedmiddle portion346 extends between the twoyolk arms342,344, and is sized to receive thetube324 therethrough. The lower pullwires316,318 extend around theyolk arms342,344, and the yolk acts as a bearing surface for the pullwires to pull thearm310 back into thecannula302. Also illustrated in FIG. 30 is anexemplary tool348 extending through thetube324, e.g., an anesthesia needle.Optional opening332 is also illustrated.

The operation of the embodiment illustrated in FIGS. 27-30 will now be described with reference to the drawing figures. Theelement300 is extended adjacent to a blood vessel of interest, as described above with reference to FIGS.126. According to an alternate embodiment of the present invention,element300 is invaginally extended adjacent to a blood vessel of interest by non-penetration, as further described herein. Optionally, anesthesia can be administered using a needle, e.g.,needle348. Once in position, theupper pullwires312,314 are pulled proximally, which rotates thearm310 out of thecannula302 and into the deployed orientation. Thereafter, a pushrod or the like, carrying a length ofsuture material154, is advanced distally through thetube304, between the wire guides306,308, laterally into the interior of thearm310 and still between the wire guides306,308, and out of thearm310. The suture is then snared by a snaring element such as those previously described, and pulled proximally, thus looping the length of suture material around the blood vessel of interest. The lower pullwires316,318 can be pulled proximally to rotate thearm310 back into thecannula302 when desired.

FIGS. 31-34 illustrate several steps of yet another exemplary method in accordance with the present invention. While FIGS. 31-34 illustrate, and the following description makes reference to,ligation device100 andligation device300, methods in accordance with the present invention are not limited to use of such devices, and other apparatus can be utilized in practicing the present methods without departing from the spirit and scope of the present invention.

FIG. 31 illustrates the device of FIG. 1 used in accordance with an exemplary embodiment of a method of ligating a uterine artery in accordance with the present invention. The distal end of aligation device100 after having been positioned proximate a vessel of interest in a patient, e.g., auterine artery420 is used to invaginate thevaginal fornix414. First, thedistal end150 ofcannula104 is inserted through thevagina412 until it approaches theartery420, e.g., up to thevaginal fornix414. Then, firstextendable member120 and secondextendable member122 are advanced distally and generally toward theartery420 to invaginate the vaginal wall and the tissue adjacent to the vaginal wall. Theartery420 is enclosed by the invaginated tissue on at least two sides without penetrating the tissue. By way of example and not by limitation, theartery420 may be identified and/or located within a tissue bundle via a Doppler wand located incannula104, as previously described.

FIG. 32 illustrates the device of FIG. 1 used in accordance with an exemplary embodiment of a method of ligating an anatomical feature in a patient by invagination. An aspect of the present invention includes a firstextendable element120 having atissue penetrating member422. Once the first and secondextendable elements120,122 are in position and have invaginated thevaginal fornix414 aroundartery420,tissue penetrating member422 is activated to penetrate the tissue bundle and ligate theartery420.Artery420 may be ligated by any of the embodiments previously described.Tissue penetrating member422 is thereafter withdrawn leaving theartery420 ligated. The procedure may then be repeated to ligate theother artery418.

FIG. 33 illustrates the device of FIG. 1 used in accordance with an exemplary embodiment of a method of ligating an anatomical feature in a patient via penetration. An aspect of the present invention includes a firstextendable element120 having atissue penetrating member422. Once the first and secondextendable elements120,122 are in position and have penetrated thevaginal fornix414 aroundartery420,tissue penetrating member422 is activated to penetrate the tissue bundle and ligate theartery420.Artery420 may be ligated by any of the embodiments previously described.Tissue penetrating member422 is thereafter withdrawn leaving theartery420 ligated. The procedure may then be repeated to ligate theother artery418.

FIG. 34 illustrates the device of FIG. 27 used in accordance with an exemplary embodiment of a method of ligating an anatomical feature in a patient by invagination. The distal end of aligation device300 after having been positioned proximate a vessel of interest in a patient, e.g., auterine artery420 is used to invaginate thevaginal fornix414. First, the distal end ofcannula302 is inserted through thevagina412 until it approaches theartery420, e.g., up to thevaginal fornix414. Then,arm310 is advanced towards theartery420 to invaginate the vaginal wall and the tissue adjacent to the vaginal wall without penetration. Theartery420 is enclosed by the invaginated tissue on at least two sides without penetrating the tissue. By way of example and not by limitation, theartery420 may be identified and/or located within a tissue bundle via a Doppler wand located incannula302, as previously described.

While the invention has been described in detail with reference to preferred embodiments thereof, it will be apparent to one skilled in the art that various changes can be made, and equivalents employed, without departing from the scope of the invention.

Claims (13)

What is claimed is:

1. A method of preparing an anatomical vessel contained within a tissue bundle for ligation, comprising the steps of:

positioning a cannula adjacent to said tissue bundle, wherein said positioning is non-penetrating, said cannula including a first extendable member, a second extendable member, a Doppler wand, and a distal end;

transmitting ultrasound signals toward said vessel through said tissue bundle with said Doppler wand;

receiving ultrasound signals reflected by said vessel through said tissue bundle with said Doppler wand;

invaginating said tissue bundle with said first extendable member on a first side of said tissue bundle;

invaginating said tissue bundle with said second extendable member on a second side of said bundle opposite said first side; and

interpenetrating a length of ligation material between said first and second extendable members on a side of said vessel opposite said cannula distal end.

2. The method as set forth toclaim 1, wherein said first extendable member includes a detachable element to which said ligation material is attached, and further comprising grabbing said detachable element with portions of said second extendable member.

3. The method as set forth toclaim 1, further comprising the steps of:

retracting said second extendable member in a proximal direction; and

releasing said detachable element from said first extendable member.

4. The method as set forth toclaim 1, wherein said first extendable member includes a tissue penetrating element to which said ligation material is attached, and further comprising piercing said tissue penetrating element into said tissue bundle.

5. The method as set forth toclaim 4, wherein said tissue penetrating element includes a detachable element to which said ligation material is attached, and further comprising grabbing said detachable element with portions of said second extendable member.

6. The method as set forth toclaim 4, further comprising the steps of:

retracting said second extendable member in a proximal direction; and

releasing said detachable element from said first extendable member.

7. A ligation device for occluding a blood vessel contained within a tissue bundle, comprising:

a cannula having a distal end that is configured for positioning adjacent the tissue bundle;

an ultrasound signals transmitter and an ultrasonic receiver configured to detect the blood vessel within tissue bundle;

a first elongated member configured to invaginate the tissue on a first side of the tissue bundle;

a second elongated member configured to invaginate the tissue on a second side of bundle opposite the first side; and

a penetrating member configured for advancing a length of ligation material between the first and second elongated members on a side of the blood vessel opposite the cannula distal end.

8. The device as set forth toclaim 7, wherein the first elongated member comprises a first extendable member having a detachable element attached to the ligation material, and further comprising a snare member configured for grabbing the detachable element.

9. The device as set forth toclaim 8, wherein second elongated member includes a second extendable member, wherein the second extendable member is further configured to be retracted in a proximal direction, and further comprising

a release mechanism configured for releasing the detachable element from the first extendable member.

10. The device as set forth toclaim 8, wherein first extendable member includes a tissue penetrating element attached to the ligation material, and further comprising a piercing element configured for piercing the tissue penetrating element into the tissue bundle.

11. The device as set forth toclaim 10, wherein the tissue penetrating element includes a detachable element attached to the ligation material, and further comprising a capture element configured for grabbing the detachable element.

12. The device as set forth toclaim 10, wherein the second elongated member is further configured to be retracted in a proximal direction, and further comprising

a release configured for releasing the detachable element from the first extendable member.

13. A ligation device for occluding a blood vessel contained within a tissue bundle, comprising:

a cannula having a distal end that is configured for positioning adjacent the tissue bundle;

an ultrasound means to detect the blood vessel within the tissue bundle;

a first elongated means to invaginate tissue on a first side of the tissue bundle;

a second elongated means to invaginate tissue on a second side of the tissue bundle opposite the first side; and

a penetrating means for advancing a length of ligation material between the first and second elongated means on a side of the blood vessel opposite the cannula distal end.

Images